NCT01111617

Brief Summary

The goal of this research program is to determine the potential effectiveness of real-time fMRI training in improving mental control over pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
3.7 years until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

9.8 years

First QC Date

January 29, 2010

Last Update Submit

March 21, 2024

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain reduction as measured by visual analog scale (VAS) pain report

    Within the 2 hour feedback session

Secondary Outcomes (1)

  • Control of brain activity as measured by fMRI analysis

    Within the 2 hour feedback session

Study Arms (1)

Real-Time fMRI

EXPERIMENTAL

Real-Time fMRI

Procedure: Real-time fMRI feedback

Interventions

Real-time fMRI feedbackPROCEDURE

Patients receive real-time fMRI biofeedback to modulate pain

Real-Time fMRI

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • Chronic Pain patient or healthy control
  • Ability to perform the experimental task

You may not qualify if:

  • MRI contraindication (metal implants, claustrophobia, pregnant or planning to become pregnant)
  • History of psychiatric disorder (at the discretion of the investigator as to whether it interferes with the experimental task)
  • History of Blistering

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sean Mackey

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 29, 2010

First Posted

April 27, 2010

Study Start

January 1, 2014

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

March 25, 2024

Record last verified: 2024-03

Locations

US(1)